Head of Regulatory Affairs Japan

1日前

Tokyo, Tokyo UCB

Make your mark for patients
患者さんのためにあなたの力を発揮してください
About The Role
We are looking for a Head of Regulatory Affairs who is strategic, collaborative, and people ‑ focused to join our Regulatory Affairs team, based in our Nishi-Shinjuku office in Tokyo, Japan.

You will lead the regulatory strategy and operations for Japan, ensuring the successful registration and life ‑ cycle management of our medicines. You will guide a team responsible for regulatory planning, execution, and compliance while partnering closely with colleagues in Japan and internationally. You will also serve as the appointed Marketing Supervisor General (Soseki) for Japan, overseeing quality assurance and post ‑ marketing safety management.

Job Summary

  • Lead regulatory strategy and planning for Japan in alignment with Japan and global business objectives
  • Guide regulatory submissions and approvals for new products and life ‑ cycle activities
  • Oversee regulatory project planning, performance indicators, and long ‑ range planning
  • Build strong partnerships across functions in Japan and internationally
  • Manage the regulatory team's budget, resources, and capability development
  • Promote regulatory understanding and compliance throughout the organization
  • Represent Japan in regulatory leadership forums and relevant industry associations
  • Drive regulatory intelligence, advocacy, and policy initiatives
  • Attract, develop, and retain a high ‑ performing regulatory team
  • Serve as the appointed Marketing Supervisor General, overseeing quality assurance and post ‑ marketing safety management

Major Accountabilities

  • Licensed Pharmacist in Japan
  • Minimum 10 years in the pharmaceutical industry, with 8+ in regulatory affairs
  • Strong leadership and people management skills, including coaching and mentoring to create an inclusive collaborative team environment
  • Experience collaborating internationally and influencing senior stakeholders
  • Strong understanding of Japan regulatory requirements and development pathways
  • Demonstrated ability to lead teams and manage regulatory authority relationships
  • Ability to solve complex problems and drive cross ‑ functional alignment
  • Strong communication skills to influence internal and external partners

患者さんのために価値を創造し、ご自身の力を発揮する準備ができているとお感じでしたら、ぜひ私たちにご連絡ください。

会社概要
UCBは、神経および免疫領域に注力するグローバルなバイオ医薬品企業です。世界中で約8,500人の社員が、患者さんからインスピレーションを受け、科学の力で前進しています。

UCBで働く魅力
UCBでは、単に業務をこなすのではなく、価値を創造することを大切にしています。私たちは挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。

誰もが尊重され、受け入れられ、最善を尽くせる平等な機会がある、思いやりと支援に満ちた文化が根付いています。

私たちは常に「その先」を目指し、患者さん、社員、そして地球に対して人間らしさを大切にした価値を提供しています。

UCBで働くことで、自分自身の成長を実感し、自由にキャリアを築き、可能性を最大限に引き出すことができます。

UCBでは機会均等を重視しています。すべての採用決定は、法律で保護されているいかなる属性にも関係なく行われます。

選考プロセスにおいて、ご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は、以下のメールアドレスまでご連絡ください:

EMEA-

※なお、この問い合わせ先では選考における特別な配慮に関するご相談以外はお受けできませんので、ご注意ください。

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